GB-0895 for Severe Uncontrolled Asthma (SOLAIRIA-2)
This study, called SOLAIRIA-2, is looking at whether GB-0895 can help adults and adolescents (ages 12 to 80) with severe asthma that isn't well-controlled by their current medications. You must have had asthma for at least two years and be on specific asthma controllers for a certain time. Participants will receive either GB-0895 or a placebo (an inactive substance) every six months for 52 weeks. The main goal is to see if GB-0895 can reduce the number of asthma attacks (exacerbations) over this period. The study aims to enroll about 786 people globally, but its current status is unclear.
- Study design
- This is a global, randomized, double-blind, placebo-controlled Phase 3 study involving approximately 786 participants.
- What's involved
- You would have visits every 1-2 months after the first month, for a total treatment period of 52 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for up to 90 weeks, or potentially up to 142 weeks if you join an optional open-label extension.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
At a glance
Conditions
Where it's being run
68 sites across 44 statesStudy leadership
- Snodgres · STUDY_DIRECTOR · Generate Biomedicines
Who to contact
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What this trial measures
- To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.From Day 1 (randomization) to Week 52
The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.